Phase 4 N=35 Randomized Double-blind Treatment

A Pilot Comparison of Short-course Nitrofurantoin in Females With Uncomplicated Bacterial Cystitis in the Emergency Department

Uncomplicated Bacterial Cystitis

Bottom Line

View on ClinicalTrials.gov: NCT01749605 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2017

Primary outcome: Primary: Number of Participants With Clinical Cure at Day 7 — 13; 12 participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days (Drug); ciprofloxacin 250 mg BID x 3 days (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: University of Iowa
Primary completion: Jan 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Clinical Cure at Day 7	13; 12	—

Summary

Pilot study to compare the efficacy and safety of 3-day, twice-daily regimens of nitrofurantoin and ciprofloxacin in emergency department (ED) patients presenting with UBC.

Eligibility Criteria

Inclusion Criteria

pre-menopausal females
ages 18-45 years old
symptoms of a UTI (dysuria, frequency, urgency)

Exclusion Criteria

Onset of symptoms >7 days prior to the ED visit
Non-English speaking
Symptoms of pyelonephritis
Diabetic
Indications of sepsis
Immunocompromised
Currently using prophylactic antimicrobials
Medications that could interfere with study drug
Pregnant
Lactating
History of kidney or liver disease
Vaginal symptoms
Presence of a urinary catheter
Treatment for UBC <2 weeks prior to ED visit
Known allergy to study drug
Unavailable for follow-up

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01749605). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.